15 JUNE, 2018
Bluebee Achieves ISO 13485 Medical Device Quality Standard Certification
Rijswijk, The Netherlands June 15, 2018 – Bluebee, a global bioinformatics solutions provider, has announced today that it has been awarded the ISO 13485:2016 certification. ISO 13485 is an internationally recognized medical device quality management systems standard, which was awarded to Bluebee for its design and development of software solutions and data processing algorithms intended for use in diagnostics and clinical reporting.
This certification is awarded for quality management systems in medical devices and adds to Bluebee’s already existing ISO/IEC 27001:2013 information security management systems certification. The achievement of this accreditation further demonstrates Bluebee’s commitment to providing quality risk-based software development, regulatory compliance, quality management, and highly secured genomic data analytical workflows to clinical laboratories and diagnostic assay kit providers.
Compliance to regulatory requirements and applicable international standards is at the core of Bluebee’s genomics software solutions and professional services. The independent certification body, BSI, has certified that Bluebee’s design, development, installation, testing and servicing of custom-made software solutions and data processing algorithms, intended for use in diagnostics and clinical reporting, conforms with ISO 13485:2016. In order to become ISO 13485:2016 certified, Bluebee had to adhere to rigorous quality management system requirements and demonstrate consistency in meeting applicable regulatory requirements. Bluebee’s achievement of the ISO 13486:2016 certification serves as an independent confirmation of the strength of the company’s quality management system (QMS) in developing tailor-made software solutions and processing algorithms for genomic data. This milestone may be leveraged by clinical laboratories and assay kit providers to meet their own quality assurance requirements and in obtaining CE IVD labelling.
“This achievement represents our commitment to providing our clinical laboratory customers and assay kit partners with the highest quality products within an environment of continuous rigor and improvement,” states Marc Gielis, Chief Operations Officer of Bluebee.
Bluebee offers a secure global bioinformatics platform to process, analyze, share, and store genomics data. Bluebee develops tailor-made data solutions for diagnostic assay manufacturers and service laboratories running high-throughput genomic assays. Bluebee supports end users in clinical diagnostics, therapeutics, and research with a shared mission—to power precision medicine. Bluebee software solutions and professional services are available across all major European countries and the United States, as well as in Canada and Asia Pacific.
To learn more, visit www.bluebee.com and follow @bluebeegenomics.
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